Release 4B Ballot #1

This page is part of the FHIR Specification (v4.1.0: Release 4B Ballot #1). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B R4 R3

Codesystem-research-study-status.xml

Biomedical Research and Regulation Work GroupMaturity Level: N/AStandards Status: Informative

Raw XML (canonical form + also see XML Format Specification)

Definition for Code System ResearchStudyStatus

<?xml version="1.0" encoding="UTF-8"?>

<CodeSystem xmlns="http://hl7.org/fhir">
  <id value="research-study-status"/> 
  <meta> 
    <lastUpdated value="2021-03-11T17:06:20.662+11:00"/> 
    <profile value="http://hl7.org/fhir/StructureDefinition/shareablecodesystem"/> 
  </meta> 
  <text> 
    <status value="generated"/> 
    <div xmlns="http://www.w3.org/1999/xhtml">
      
      
      <h2> ResearchStudyStatus</h2> 
      
      
      <div> 
        
        
        <p> Codes that convey the current status of the research study.</p> 

      
      
      </div> 
      
      
      <p> This code system http://hl7.org/fhir/research-study-status defines the following codes:</p> 
      
      
      <table class="codes">
        
        
        <tr> 
          
          
          <td style="white-space:nowrap">
            
            
            <b> Code</b> 
          
          
          </td> 
          
          
          <td> 
            
            
            <b> Display</b> 
          
          
          </td> 
          
          
          <td> 
            
            
            <b> Definition</b> 
          
          
          </td> 
        
        
        </tr> 
        
        
        <tr> 
          
          
          <td style="white-space:nowrap">active
            
            
            <a name="research-study-status-active"> </a> 
          
          
          </td> 
          
          
          <td> Active</td> 
          
          
          <td> Study is opened for accrual.</td> 
        
        
        </tr> 
        
        
        <tr> 
          
          
          <td style="white-space:nowrap">administratively-completed
            
            
            <a name="research-study-status-administratively-completed"> </a> 
          
          
          </td> 
          
          
          <td> Administratively Completed</td> 
          
          
          <td> Study is completed prematurely and will not resume; patients are no longer examined nor
             treated.</td> 
        
        
        </tr> 
        
        
        <tr> 
          
          
          <td style="white-space:nowrap">approved
            
            
            <a name="research-study-status-approved"> </a> 
          
          
          </td> 
          
          
          <td> Approved</td> 
          
          
          <td> Protocol is approved by the review board.</td> 
        
        
        </tr> 
        
        
        <tr> 
          
          
          <td style="white-space:nowrap">closed-to-accrual
            
            
            <a name="research-study-status-closed-to-accrual"> </a> 
          
          
          </td> 
          
          
          <td> Closed to Accrual</td> 
          
          
          <td> Study is closed for accrual; patients can be examined and treated.</td> 
        
        
        </tr> 
        
        
        <tr> 
          
          
          <td style="white-space:nowrap">closed-to-accrual-and-intervention
            
            
            <a name="research-study-status-closed-to-accrual-and-intervention"> </a> 
          
          
          </td> 
          
          
          <td> Closed to Accrual and Intervention</td> 
          
          
          <td> Study is closed to accrual and intervention, i.e. the study is closed to enrollment, all
             study subjects have completed treatment or intervention but are still being followed according
             to the primary objective of the study.</td> 
        
        
        </tr> 
        
        
        <tr> 
          
          
          <td style="white-space:nowrap">completed
            
            
            <a name="research-study-status-completed"> </a> 
          
          
          </td> 
          
          
          <td> Completed</td> 
          
          
          <td> Study is closed to accrual and intervention, i.e. the study is closed to enrollment, all
             study subjects have completed treatment
or intervention but are still being followed according to the primary objective of the
             study.</td> 
        
        
        </tr> 
        
        
        <tr> 
          
          
          <td style="white-space:nowrap">disapproved
            
            
            <a name="research-study-status-disapproved"> </a> 
          
          
          </td> 
          
          
          <td> Disapproved</td> 
          
          
          <td> Protocol was disapproved by the review board.</td> 
        
        
        </tr> 
        
        
        <tr> 
          
          
          <td style="white-space:nowrap">in-review
            
            
            <a name="research-study-status-in-review"> </a> 
          
          
          </td> 
          
          
          <td> In Review</td> 
          
          
          <td> Protocol is submitted to the review board for approval.</td> 
        
        
        </tr> 
        
        
        <tr> 
          
          
          <td style="white-space:nowrap">temporarily-closed-to-accrual
            
            
            <a name="research-study-status-temporarily-closed-to-accrual"> </a> 
          
          
          </td> 
          
          
          <td> Temporarily Closed to Accrual</td> 
          
          
          <td> Study is temporarily closed for accrual; can be potentially resumed in the future; patients
             can be examined and treated.</td> 
        
        
        </tr> 
        
        
        <tr> 
          
          
          <td style="white-space:nowrap">temporarily-closed-to-accrual-and-intervention
            
            
            <a name="research-study-status-temporarily-closed-to-accrual-and-intervention"> </a> 
          
          
          </td> 
          
          
          <td> Temporarily Closed to Accrual and Intervention</td> 
          
          
          <td> Study is temporarily closed for accrual and intervention and potentially can be resumed
             in the future.</td> 
        
        
        </tr> 
        
        
        <tr> 
          
          
          <td style="white-space:nowrap">withdrawn
            
            
            <a name="research-study-status-withdrawn"> </a> 
          
          
          </td> 
          
          
          <td> Withdrawn</td> 
          
          
          <td> Protocol was withdrawn by the lead organization.</td> 
        
        
        </tr> 
      
      
      </table> 
    
    
    </div> 
  </text> 
  <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
    <valueCode value="brr"/> 
  </extension> 
  <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
    <valueCode value="trial-use"/> 
  </extension> 
  <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm">
    <valueInteger value="1"/> 
  </extension> 
  <url value="http://hl7.org/fhir/research-study-status"/> 
  <identifier> 
    <system value="urn:ietf:rfc:3986"/> 
    <value value="urn:oid:2.16.840.1.113883.4.642.4.820"/> 
  </identifier> 
  <version value="4.1.0"/> 
  <name value="ResearchStudyStatus"/> 
  <title value="ResearchStudyStatus"/> 
  <status value="draft"/> 
  <experimental value="false"/> 
  <date value="2021-01-17T07:06:13+11:00"/> 
  <publisher value="HL7 (FHIR Project)"/> 
  <contact> 
    <telecom> 
      <system value="url"/> 
      <value value="http://hl7.org/fhir"/> 
    </telecom> 
    <telecom> 
      <system value="email"/> 
      <value value="fhir@lists.hl7.org"/> 
    </telecom> 
  </contact> 
  <description value="Codes that convey the current status of the research study."/> 
  <caseSensitive value="true"/> 
  <valueSet value="http://hl7.org/fhir/ValueSet/research-study-status"/> 
  <content value="complete"/> 
  <concept> 
    <code value="active"/> 
    <display value="Active"/> 
    <definition value="Study is opened for accrual."/> 
  </concept> 
  <concept> 
    <code value="administratively-completed"/> 
    <display value="Administratively Completed"/> 
    <definition value="Study is completed prematurely and will not resume; patients are no longer examined nor
     treated."/> 
  </concept> 
  <concept> 
    <code value="approved"/> 
    <display value="Approved"/> 
    <definition value="Protocol is approved by the review board."/> 
  </concept> 
  <concept> 
    <code value="closed-to-accrual"/> 
    <display value="Closed to Accrual"/> 
    <definition value="Study is closed for accrual; patients can be examined and treated."/> 
  </concept> 
  <concept> 
    <code value="closed-to-accrual-and-intervention"/> 
    <display value="Closed to Accrual and Intervention"/> 
    <definition value="Study is closed to accrual and intervention, i.e. the study is closed to enrollment, all
     study subjects have completed treatment or intervention but are still being followed according
     to the primary objective of the study."/> 
  </concept> 
  <concept> 
    <code value="completed"/> 
    <display value="Completed"/> 
    <definition value="Study is closed to accrual and intervention, i.e. the study is closed to enrollment, all
     study subjects have completed treatment
or intervention but are still being followed according to the primary objective of the
     study."/> 
  </concept> 
  <concept> 
    <code value="disapproved"/> 
    <display value="Disapproved"/> 
    <definition value="Protocol was disapproved by the review board."/> 
  </concept> 
  <concept> 
    <code value="in-review"/> 
    <display value="In Review"/> 
    <definition value="Protocol is submitted to the review board for approval."/> 
  </concept> 
  <concept> 
    <code value="temporarily-closed-to-accrual"/> 
    <display value="Temporarily Closed to Accrual"/> 
    <definition value="Study is temporarily closed for accrual; can be potentially resumed in the future; patients
     can be examined and treated."/> 
  </concept> 
  <concept> 
    <code value="temporarily-closed-to-accrual-and-intervention"/> 
    <display value="Temporarily Closed to Accrual and Intervention"/> 
    <definition value="Study is temporarily closed for accrual and intervention and potentially can be resumed
     in the future."/> 
  </concept> 
  <concept> 
    <code value="withdrawn"/> 
    <display value="Withdrawn"/> 
    <definition value="Protocol was withdrawn by the lead organization."/> 
  </concept> 
</CodeSystem>

Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.